【CODEX翻译】中华人民共和国药品管理法（4-6）-EN
第四章 医疗机构的药剂管理
Chapter IV Control over Pharmaceuticals in Medical Institutions
第二十二条 医疗机构必须配备依法经过资格认定的药学技术人员。非药学技术人员不得直接从事药剂技术工作。
Article 22.Medical institutions shall be staffed with legally qualified pharmaceutical professionals. No one who is not a pharmaceutical professional shall directly be engaged in technical work in pharmacy.
第二十三条 医疗机构配制制剂，须经所在地省、自治区、直辖市人民政府卫生行政部门审核同意，由省、自治区、直辖市人民政府药品监督管理部门批准，发给《医疗机构制剂许可证》。无《医疗机构制剂许可证》的，不得配制制剂。
Article 23.To dispense pharmaceutical preparations, a medical institution shall be subject to examination and permission by the administrative authority for health of the people’s government of the province, autonomous region or municipality directly under the Central Government, and upon approval by the drug regulatory authority of the said people’s government, a Pharmaceutical Preparation Certificate for Medical Institution shall be issued to it by the said drug regulatory authority. No one shall dispense pharmaceutical preparations without the certificate.
